MAUDE Adverse Event Report: CARDINAL HEALTH 450 SAL EJECTOR 3283; MOUTHPIECE, SALIVA EJECTOR

Model Number 8881450004

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2022

Event Type  malfunction  

Event Description

The customer reported that they have a safety issue with a product that is used daily in their gastrointestinal (gi) procedures.Per customer, this is a saliva ejector that is used to suck out the saliva out of a patient¿s mouth while they are sedated, much like a dentist¿s office, unfortunately, the small plastic blue piece has been falling off very easily.The issue was noticed when used on a patient.There was no patient harm reported.The customer further stated that they are still using the product with a new protocol around pulling on the blue tip first to make sure it¿s seated and not loose.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A sample was not received for the investigation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.At this time, a corrective and preventive action is not deemed necessary.The current process is running according to product specifications, meeting all quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: 450 SAL EJECTOR 3283
• Type of Device: MOUTHPIECE, SALIVA EJECTOR
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13471004
• MDR Text Key: 285226890
• Report Number: 9612030-2022-03158
• Device Sequence Number: 1
• Product Code: DYN
• UDI-Device Identifier: 10884521020337
• UDI-Public: 10884521020337
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8881450004
• Device Catalogue Number: 8881450004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1